R. Yamaguchi

AB0211 Which Disease Activity Score 28 (DAS28) Based Flare Criteria Impact on Functional Disability in Patients with Ra in Das28 Remission State Using The IORRA Cohort

Background The therapeutic goal for patients with rheumatoid arthritis (RA) is achieving remission state or at least low disease activity state. We demonstrated that sustaining remission leads to good functional disability at1). However, not a few patients flared after achieving remission state in daily practice. Several published Disease Activity Score 28 (DAS28) based flare criteria are reported2–5). It is useful to investigate which DAS28 based flare criteria lead to functional disability. Objectives To investigate associations between DAS28 based flare criteria and functional disability in RA patients after achieving DAS28 remission in daily practice using the large, observational, Institute Of Rheumatology, Rheumatoid Arthritis (IORRA) cohort. Methods The IORRA survey has been conducted biannually. RA patients with DAS28 remission in April 2012 (baseline) and participated in both subsequent surveys in October 2012 and October 2013 were extracted from the IORRA cohort. Flare in each patient was evaluated according to four previously published DAS28 based flare criteria [(1) increase in DAS28 >1.2 (2) increase in DAS28 >0.6 or if a DAS28 ≧3.2 (3) reaching DAS28>3.2 (4) reaching DAS28>2.6]2–5) in October 2012. Functional disability was assessed by validated Japanese version of the Health Assessment Questionnaire (J-HAQ)6) in April 2012 and October 2013. Change in J-HAQ (ΔJ-HAQ) score was defined as follows: ΔJ-HAQ = J-HAQ score in April 2012 - J-HAQ score in April 2012. Average ΔJ-HAQ score in patients achieving each flare criteria was calculated. The association between ΔJ-HAQ as outcome and achieving each flare criteria as explanatory variable was analyzed using multiple regression analysis adjusting for gender, age, disease duration, pain (Visual Analogue Scale) VAS, general VAS and J-HAQ score at baseline. Results A total of 1,874 patients were analyzed. Females comprised 80.6% of the study population. The mean (SD) age and disease duration were 58.2 (12.7) years and 11.9 (8.9) years, respectively. The mean (SD) DAS28 and J-HAQ score were 2.0 (0.5) and 0.3 (0.5), respectively. Proportions of the patients met each flare criteria in October 2012 were (1) 9.7% (2) 24.4% (3) 11.3% and (4) 28.1%, respectively. Average ΔJ-HAQ score in patients met each flare criteria was (1) 0.13, (2) 0.06, (3) 0.10, and (4) 0.05, respectively. Multiple regression analysis demonstrated that achieving each flare criteria significantly associated with increase in J-HAQ score; (1) 0.11 (p<0.001), (2) 0.05 (p=0.0003), (3) 0.10 ((p≤0.001), and (4) 0.04 (p=0.0012), respectively. Conclusions Regardless of flare criteria, flares resulted in progressed functional disability in patients with RA. Aachieving flare criteria using (1) increase in DAS28 >1.2 and (3) reaching DAS28>3.2 led to worse physical functional outcome, suggesting that usage of these flare criteria might predict functional disability. References Shidara K et al., the 2011 American College of Rheumatology annual meeting Smolen JS et al., Ann Rheum Dis 2007;66:143–50 VanderCruyssen B et al.,Arthritis Res Ther 2010;12:R169 Assous N et al., J Rheumatol 2008;35:31–4 Emery P et al., Ann Rheum Dis 2010;69:1629–35 Matsuda Y et al., Arthritis Rheum 2003;49:784–8 Disclosure of Interest K. Shidara: None declared, E. Tanaka Speakers bureau: ET has received speaker fees or consulting fees from Abbvie, Eisai Pharmaceutical, Chugai Pharmaceutical, Bristol Myers Squibb, Astellas Pharmaceutical, Pfizer, Takeda Pharmaceutical, and Santen Pharmaceutical., E. Inoue: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, D. Hoshi: None declared, N. Sugimoto: None declared, A. Nakajima: None declared, S. Momohara Speakers bureau: SM has received speaker fees from Abbott, AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe, Pfizer, Takeda, and Teijin., A. Taniguchi: None declared, H. Yamanaka Speakers bureau: HY has received speaker fees from Abbott, AbbVie, Asahikasei, Astellas,AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, MSD,Nippon Kayaku, Pfizer, Santen, Taishotoyama, Takeda, and Teijin.

THU0046 A 3-Year Study of Work Impairment in Patients with Rheumatoid Arthritis Based on The IORRA Cohort

Background Indirect costs of rheumatoid arthritis (RA) due to losses such as reduced productivity are an important social issue in addition to rapidly increasing direct costs; however, work disability in patients with RA have not been thoroughly assessed in Japan. With the recent changes in socioeconomic structure, the number of female paid workers has been increasing; thus, the impact of RA on the work impairment of Japanese patients has been rapidly increasing. In addition, work status is strongly influenced by cultural differences among races. Furthermore, with the recent improvement of RA treatment strategy, it has not been evaluated whether work disability in patients with RA improved or not in a real world settings. Hence, we evaluated longitudinally work impairment in patients with RA in daily practice using a large cohort database. Objectives To study how the magnitude of work impairment in Japanese patients with rheumatoid arthritis (RA) has changed over the past 3 years in routine clinical practice. Methods Patients with RA who participated in both of the IORRA studies conducted in April 2012 and April 2013 and those who worked for pay on both surveys and were aged 55 years or younger at baseline were identified. Changes over the 3 years in the absenteeism (AB), presenteeism (PR) and overall work impairment (OWI) scores as determined by the Work Productivity and Activity Impairment (WPAI) were evaluated in those patients. In addition, patients with work impairment, defined as AB >0% or PR ≥30%, at baseline were classified according to whether or not they still had work impairment at 3 years to identify differences in their characteristics. Results Among 4,214 patients with RA who participated in both of the IORRA studies, 1,310 patients were selected in this study cohort (mean age, 51.5 years; females, 80.1%; Japanese version of the HAQ [J-HAQ], 0.37). The AB, PR, OWI scores in the 1310 patients were 1.8%, 16.4% and 17.3%, respectively, at baseline, which remained unchanged at 3 years (2.1%, 16.4% and 17.6%, respectively). At baseline, 206 patients (15.7%) had work impairment, of whom 117 patients (56.8%) (mean age, 43.8 years; females, 85.5%; DAS28, 3.1 [2.8 at 3 years]; J-HAQ, 0.80 [0.75 at 3 years]; 73.5% [76.9% at 3 years] of patients received methotrexate; 36.8% [38.5% at 3 years] received biologics) continued to have it at 3 years, and 89 patients (43.2%) (mean age, 44.2 years; females, 84.3%; DAS28, 3.2 [2.1 at 3 years]; J-HAQ, 0.54 [0.25 at 3 years]; 77.5% [82.0% at 3 years] of patients received methotrexate; 24.7% [39.3% at 3 years] received biologics) were free from work impairment. Conclusions In the overall population of Japanese patients with RA, work impairment has not been improved over the past 3 years; however, as many as 43.2% of patients with work impairment at baseline have experienced improved work productivity. In these patients, more intensive RA therapy has resulted in a greater reduction in disease activity or functional impairment. Disclosure of Interest E. Tanaka Speakers bureau: ET has received speaker fees or consulting fees from Abbvie, Eisai Pharmaceutical, Chugai Pharmaceutical, Bristol Myers Squibb, Astellas Pharmaceutical, Pfizer, Takeda Pharmaceutical, and Santen Pharmaceutical., E. Inoue: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, N. Sugimoto: None declared, D. Hoshi: None declared, K. Shidara: None declared, E. Sato: None declared, Y. Seto: None declared, A. Nakajima: None declared, S. Momohara Speakers bureau: SM has received speaker fees from Abbott, AbbVie, Astellas, Bristol-Myers Squibb, Chugai, Eisai, Mitsubishi Tanabe, Pfizer, Takeda, and Teijin., A. Taniguchi: None declared, H. Yamanaka Speakers bureau: HY has received speaker fees from Abbott, AbbVie, Asahikasei, Astellas, AstraZeneca, Bristol-Myers Squibb, Chugai, Daiichi Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taishotoyama, Takeda, and Teijin.

SAT0093 Association of Alcohol Consumption with Disease Activity in Patients with Rheumatoid Arthritis Using the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) Cohort

Background While the results of several observational studies suggest that light-to-moderate alcohol consumption may decrease the risk for susceptibility to or severity of rheumatoid arthritis (RA) (1-3), the findings regarding alcohols effect on RA disease activity have been inconsistent. Although alcohol consumption in the Japanese general population was lower than that in European countries according to the 2011 World Health Organizations Global Status Report on Alcohol and Health, there are few reports on alcohol consumption in Japanese RA patients. Objectives To examine the relationship between alcohol consumption and disease activity in RA patients using the large observational cohort, IORRA. Methods Subjects were RA patients who participated in the IORRA study for the first time between October 2007 and October 2012. Patients were divided into 6 groups by alcohol-drinking status at baseline: the non-drinking group, the past-drinking group, drinking group 1 (0 g < amount of drinking per day [Alco-drink] 14 g), drinking group 2 (14 g < Alco-drink 28 g), drinking group 3 (28 g < Alco-drink 50 g), and drinking group 4 (50 g < Alco-drink). Multiple regression analyses were used to examine the relationship between alcohol consumption and baseline DAS28 or change in DAS28 from baseline to 1 year. Results Data from 2,369 patients (female: 83.6%, mean age: 54.6 years old, mean disease duration: 5.6 years, and mean DAS28: 3.5) were analyzed. The number of patients and their characteristics (% female, mean age, mean disease duration, mean DAS28 at baseline/after 1 year) in the non-drinking group, the past-drinking group, and drinking groups 1, 2, 3, and 4 were 1,436 (90.5%, 55.6 years old, 6.0 years, 3.6/2.9), 294 (83.3%, 53.7 years old, 4.7 years, 3.9/2.8), 263 (79.5%, 50.6 years old, 5.6 years, 3.3/2.6), 124 (66.1%, 53.6 years old, 3.6 years, 3.2/2.5), 111 (58.6%, 57.4 years old, 5.0 years, 3.4/2.8), and 114 (49.1%, 51.4 years old, 4.5 years, 3.3/2.6), respectively. Multivariate regression analysis confirmed that the baseline DAS28 in the past-drinking group (p<0.001) was significantly higher than that in the non-drinking group after adjusting for age, gender, RA disease duration and body mass index (BMI), whereas the baseline DAS28 in drinking group 1 (p=0.04) and group 2 (p=0.01) was significantly lower than that in the non-drinking group after adjusting for the same variables. There was no association between alcohol-drinking status and the change in DAS28 from baseline to 1 year after adjusting for age, gender, RA disease duration, BMI and DAS28 at baseline. Conclusions Although light alcohol consumption was associated with lower baseline DAS28 in RA patients, alcohol-drinking status was not associated with response to RA treatment. References Di Giuseppe D. BMJ, 2012 Jul 10;345:e4230. Kallberg H. Ann Rheum Dis, 2009;68:222-7. Maxwell JR. Rheumatology (Oxford), 2010;49:2140-6. Disclosure of Interest Y. Shimizu: None declared, K. Shidara: None declared, E. Tanaka: None declared, E. Inoue: None declared, R. Yamaguchi: None declared, N. Sugimoto: None declared, D. Hoshi: None declared, A. Nakajima: None declared, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda., A. Taniguchi Grant/research support from: Takeda., Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin., H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin Pharma., Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, UCB.

THU0161 The Incidence of Malignancies in Japanese Patients with Rheumatoid Arthritis Enrolled in the Iorra Cohort During a 14-Year Observation Period

Background The overall incidence of malignancies in patients with rheumatoid arthritis (RA) has been reported to be comparable or slightly higher than that in general population, whereas the increased incidence of malignant lymphoma has been reported to be consistent in most studies, including our previous report.1-3 However, the impact of expand use of methotrexate (MTX) and biological agents on the incidence of malignancies has not been thoroughly examined. Objectives To examine the incidence of malignancies in a large observational cohort of Japanese patients with RA over a long-term period. Methods The Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort is a large, single institute-based, observational cohort of RA patients established at our institute in 2000. All malignancies were extracted from the biannual self-reports of Japanese RA patients enrolled in the IORRA cohort from 2000 to 2013 and confirmed by their medical records. Patients with RA who dropped out of the IORRA were asked about comorbidities including malignancies by follow-up mail. For the overall malignancies and malignancies at each site, the standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) were calculated according to the data from the general Japanese population. Results Data from 11,106 patients with RA (1,992 males; 9,114 females), including 122,706 person-years (19,597 males; 103,109 females), were analysed. Percentages of MTX and biologics user increased from 34.2% and 0% in 2000, respectively, to 77.5% and 19.8% in 2013, respectively, in the IORRA. A total of 830 overall malignancies were confirmed (676.4 malignancies/100,000 person-years, SIR 0.96, 95% CI 0.90-1.03). Malignant lymphoma and lung cancer were the most frequent types of malignancy (114 cases each). A significant increase in the SIR was identified for malignant lymphoma in both males (SIR 4.62, 95% CI 3.04-6.72) and females (SIR 5.27, 95% CI 4.22-6.50) and for lung cancer in males (SIR 1.36, 95% CI 1.03-1.75). A significant decrease in the SIR was identified for gastric cancer in both males (SIR 0.58, 95% CI 0.39-0.82) and females (SIR 0.77, 95% CI 0.60-0.99) and for colorectal cancer in both males (SIR 0.53, 95% CI 0.35-0.78) and females (SIR 0.56, 95% CI 0.43-0.71). Conclusions No significant difference in the overall incidence of malignancies in Japanese patients with RA was noted compared with the general Japanese population regardless of the expand use of MTX and biological agents in this period. However, there was a significant difference in the sites of the malignancies. A marked significant increase in the incidence of malignant lymphoma in both males and females was observed. References Smitten AL, et al. Arthritis Res Ther 2008;10:R45. Wolfe F, et al. Arthritis Rheum 2004;50:1740-51. Yamada T, et al. Rheumatol Int 2011;31:1487-92. Disclosure of Interest N. Sugimoto: None declared, E. Tanaka: None declared, E. Inoue: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, A. Kobayashi: None declared, K. Shidara: None declared, D. Hoshi: None declared, A. Nakajima: None declared, A. Taniguchi Grant/research support from: Takeda, Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda, H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin Pharma, Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, UCB

FRI0074 Status of Disease Activity, Functional Impairment and Treatment in Patients with Rheumatoid Arthritis and Comorbidities

Background Rheumatoid arthritis (RA) reduces functional ability and quality of life. Comorbidities may have considerable impact on physical function, and functional disability consistently increases with higher levels of comorbidity, irrespective of RA disease activity (1). We reported that patients with many comorbidities were treated less frequently with methotrexate (MTX) and biologics and tended to exhibit corticosteroid dependency, resulting in worse physical function (2); however, the effects of different comorbidities on treatment strategy and subsequent outcomes, such as disease activity and physical function, have not been evaluated. Objectives To assess disease activity, functional impairment and treatment in Japanese RA patients with comorbidities in daily practice. Methods Among the patients who participated in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) study in October 2013, we extracted those who answered “yes” to the question, “Have you ever had or do you currently have any of the following diseases?”, and cross-sectionally assessed patient characteristics, disease activity, functional impairment and treatment by comorbidity: (1) angina pectoris/myocardial infarction (coronary artery disease [CAD]), (2) cerebral hemorrhage/cerebral infarction/subarachnoid hemorrhage (stroke), (3) hypertension, (4) heart failure, (5) interstitial pneumonia (IP), (6) pulmonary emphysema/chronic bronchitis/asthma/bronchiectasis (chronic obstructive pulmonary disease [COPD]), (7) gastric ulcer/duodenal ulcer/gastrointestinal hemorrhage (GI), (8) hepatic dysfunction/viral hepatitis, (9) cancer, (10) depression, (11) diabetes, (12) fracture. Results The study included 5,837 patients with RA (mean age, 60.9 y; RA duration, 14.8 y; females, 85.5%; DAS28, 2.6; Japanese version of the HAQ [J-HAQ] score, 0.59; percentage of patients receiving MTX/corticosteroid/biologics, 77.4%/33.2%/18.8%). The most common comorbidity was hypertension (19.3%), followed by COPD (4.7%), GI (4.5%), diabetes (4.4%), fracture (4.0%) and IP (2.8%). The mean age was highest in patients with CAD (71.6 y) and lowest in those with depression (58.1 y). The mean DAS28 was below 3.0, except in patients with IP (3.2) and cancer (3.0), whereas all comorbidities except hypertension and diabetes (0.78) had a J-HAQ score of 0.8 or more; in particular, fracture (1.04) and IP (1.01) were associated with more advanced functional impairment. The percentage of patients receiving MTX was lowest for IP (47.6%) and heart failure (55.3%) and highest for depression (77.3%). The percentage of patients receiving corticosteroids was highest for IP (68.1%) and lowest for diabetes (36.3%). The percentage of patients receiving biologics was highest for IP (25.9%) and depression (21.8%), and lowest for cancer (12.5%). Conclusions Although the choice of RA therapy varies among different comorbidities, current RA therapy provides adequate control to achieve low disease activity or remission in most patients. However, progression of functional impairment cannot be avoided in the presence of comorbidities, suggesting the importance of prevention and treatment of comorbidities, in addition to the control of RA disease activity. References Radner H. Ann Rheum Dis 2010. Nakajima A. Clin Rheumatol 2014. Disclosure of Interest E. Tanaka: None declared, E. Inoue: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, N. Sugimoto: None declared, D. Hoshi: None declared, K. Shidara: None declared, E. Sato: None declared, Y. Seto: None declared, A. Nakajima: None declared, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda., A. Taniguchi Grant/research support from: Takeda., Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin., H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, and Teijin Pharma., Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB.

FRI0046 Methotrexate Dose Reduction During DAS28 Remission was a Significant Factor Associated with Early Deterioration in Patients with Rheumatoid Arthritis from the Iorra Cohort

Background Maintenance of remission is an important therapeutic goal in rheumatoid arthritis (RA). Several studies have proposed that RA patients maintaining remission could alter their current RA treatment strategy by reducing or withdrawing biological therapy1)2). However, few studies have investigated what factors lead to the loss of remission in a short period of time in RA patients who had previously sustained a remission state. Objectives To investigate the risk factors for early deterioration after sustained DAS28 remission in RA patients in daily practice by using the large, observational, Institute Of Rheumatology, Rheumatoid Arthritis (IORRA) cohort, in which data were collected biannually. Methods RA patients were selected for this study if they were not in DAS28 remission between October 2008 and October 2009 but subsequently achieved and sustained DAS28 remission at two consecutive data collections. These patients were observed to determine if DAS28 remission was maintained for 3 years. Cox regression analyses were conducted to examine risk factors for early deterioration within 3 years after sustained DAS28 remission at two consecutive data collections (1-year DAS28 remission). Results A total of 841 patients with a sustained 1-year DAS28 remission state were analyzed. Females comprised 83% of the study population. The mean (SD) age and disease duration were 57.3 (13.0) years and 11.9 (8.8) years, respectively. The mean (SD) DAS28 and Japanese version of the Health Assessment Questionnaire (J-HAQ) score were 2.1 (0.4) and 0.4 (0.5), respectively. The mean (SD) methotrexate dosage and percentage of biologic use was 8.4 (3.3) mg/week and 18%, respectively. The proportions of the patients whose disease activity deteriorated within 1, 2 or 3 years after a sustained 1-year DAS28 remission state were 41.4%, 57.0% and 64.4%, respectively. Cox regression analyses confirmed that longer disease duration (p=0.045), higher DAS28 score during a 1-year DAS28 remission (p<0.0001), and decrease in methotrexate dose during the DAS28 remission state (p=0.03) were the significant factors associated with early deterioration from the DAS28 remission state. Conclusions A decrease in the methotrexate dose during DAS28 remission was a significant factor associated with early deterioration in patients with RA in daily practice. Methotrexate dose reductions should be done prudently even in patients with sustained DAS28 remission. References Smolen JS et al., Lancet. 2013;381:918-29. Tanaka Y et al., Clin Exp Rheumatol 2013;31:S22-7 Disclosure of Interest K. Shidara: None declared, E. Inoue: None declared, E. Tanaka: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, D. Hoshi: None declared, N. Sugimoto: None declared, A. Nakajima: None declared, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda, A. Taniguchi Grant/research support from: Takeda, Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin, H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin Pharma, Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, UCB

SAT0068 A Longitudinal Study of Factors Contributing to the Worsening of Absenteeism in Patients with Rheumatoid Arthritis Based on the Iorra Cohort

Background Indirect costs of rheumatoid arthritis (RA) due to losses such as reduced productivity are an important social issue in addition to rapidly increasing direct costs; however, indirect costs have not been thoroughly assessed in Japan. With the recent changes in socioeconomic structure, the number of female paid workers has been increasing; thus, the impact of RA on the work impairment of Japanese patients has been rapidly increasing. Furthermore, work status is strongly influenced by cultural differences among races. Longitudinal analyses of factors contributing to the worsening of work impairment should be conducted in patients with RA in real-world settings. Objectives To identify factors contributing to early worsening of absenteeism in patients with RA in daily practice. Methods The study population consisted of patients with RA who were working for pay and who participated in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort study in 2012 to 2013, had an absenteeism score of 0 as determined by the Work Productivity and Activity Impairment (WPAI) questionnaire at baseline, and could be followed up for WPAI assessments for at least 6 months to a maximum of 18 months. The time to 10% or more absenteeism (percent work time missed due to RA) was the primary outcome. A Cox regression analysis was used to identify factors contributing to the worsening of absenteeism. Results The study included 1,941 patients with RA (mean age, 50.6 years; RA duration, 10.8 years; females, 79.3%; DAS28, 2.6; Japanese version of the Health Assessment Questionnaire [J-HAQ], 0.32). Absenteeism first exceeded 10% at 6, 12 and 18 months in 47 (cumulative probability of worsening: 2.4% [95% CI: 1.7%>3.1%]), 33 (4.5% [95% CI: 3.5%>5.4%]) and 20 (6.2% [95% CI: 5.0%>7.4%]) patients, respectively. Results of a multivariate Cox regression analysis showed that lower EQ-5D scores at baseline (p=0.01) and steroid dosage at baseline (p=0.01) were significantly associated with earlier worsening of absenteeism, and that the use of biologics did not have a significant impact (p=0.46). Conclusions Factors contributing to earlier worsening of absenteeism were identified in patients with RA in daily practice. The results suggest that preventing quality of life deterioration without steroid use might be important in stopping the progression of work impairment. Disclosure of Interest E. Tanaka: None declared, E. Inoue: None declared, R. Yamaguchi: None declared, Y. Shimizu: None declared, N. Sugimoto: None declared, D. Hoshi: None declared, K. Shidara: None declared, E. Sato: None declared, Y. Seto: None declared, A. Nakajima: None declared, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda., A. Taniguchi Grant/research support from: Takeda., Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin., H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, and Teijin Pharma., Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, and UCB.

AB0387 Incidence and Risk Factors for Tuberculosis in Japanese Patients with Rheumatoid Arthritis During a 12-Year Observational Period Using the Iorra Cohort

Background A high incidence of tuberculosis (TB) in patients with rheumatoid arthritis (RA) has been reported [1]. The incidence of TB has increased with the widespread use of biologics, such as tumor necrosis factor-alpha (TNF-a) [2]; however, there has been no recent increase in the incidence of TB because of the management and screening before initiating biologics [3]. According to our previous report on the incidence of TB in Japanese patients with RA enrolled in the Institute of Rheumatology, Rheumatoid Arthritis (IORRA) cohort, the standardized incidence ratio (SIR) of TB was high [4]; however, the frequency of biologics use is on the rise. Hence, we examined the incidence of TB in RA patients over a long-term period. Objectives To determine the incidence and risk factors for TB in Japanese RA patients during a 12-year observational period in daily practice. Methods We established a large observational cohort of RA patients, IORRA cohort in 2000. Among the patients with RA enrolled in the IORRA cohort, all TB cases that developed during the observational period were extracted based on patient self-reporting biannually (at least two times between 2002 and 2013) and confirmed by medical records. We calculated the SIR of TB according to the incidence of TB in the general Japanese population from the Prevention Committee of the Japanese Society for Tuberculosis. Risk factors for TB were examined using a multiple time-dependent Cox regression model. The explanatory variables were age, gender, body mass index, DAS28-CRP, Japanese version of Health Associated Questionnaire, and biologics, methotrexate, and steroid use. Results Among 10,415 patients with RA (males, 1,823; females, 8,592) with 108,175 patient-years of follow-up (males, 17,035; females, 91,140), 23 TB cases (average age, 56.2 years; RA duration, 8.7 years; males, 32%; steroid use, 56.5% [mean dose =5.0 mg/day]; biologics use, 21.7%; extrapulmonary TB, 43.5%) were confirmed as the cases in this study. Of the 23 TB cases, 5 developed during treatment with biologics (infliximab, 2; etanercept, 2; adalimumab, 1), 2 of 5 cases (infliximab and etanercept, 1 each) developed TB after 9 months of isoniazid (INH) treatment and 1 case (infliximab) developed TB while taking INH. The incidence of TB per 100,000 patient-years of follow-up was 13.7 (95% CI: 5.5-28.4). The SIRs of TB were 0.85 (95% CI: 0.54-1.27) in all RA patients, 0.84 (95% CI: 0.36-1.66) in males, and 0.85 (95% CI: 0.48-1.40) in females. The risk factors for TB were male (p<0.01), older age (p<0.05), low BMI (p<0.01), and biologics use (p<0.05), although steroid and methotrexate use was not a risk factor. Conclusions As a result of long-term follow-up (12 years), there was no significant difference in the incidence of TB in Japanese RA patients compared to the general population. Biologics use was a significant risk factor for TB. References Weisman MT et al., J Rheumatol 2002; 29 (Suppl 65): 33-8. Dixon WG et al., Ann Rheum Dis 2010; 69: 522-8. Sichletidis L et al., Int J Tuberc Lung Dis 2006; 10: 1127-32. Yamada T et al., Ann Rheum Dis 2006; 65: 1661-3. Disclosure of Interest R. Yamaguchi: None declared, K. Shidara: None declared, E. Tanaka: None declared, E. I. Inoue: None declared, Y. Shimizu: None declared, A. Kobayashi: None declared, N. Sugimoto: None declared, D. Hoshi: None declared, E. Sato: None declared, Y. Seto: None declared, A. Nakajima: None declared, S. Momohara Consultant for: AbbVie, Bristol-Myers-Squibb, Eisai, Mitsubishi-Tanabe, and Takeda, A. Taniguchi Grant/research support from: Takeda, Consultant for: AbbVie, Eisai, Mitsubishi-Tanabe, and Teijin, H. Yamanaka Grant/research support from: AbbVie, Asahikasei Pharma, Astellas, Bristol-Myers-Squibb, Chugai, Daiichi-Sankyo, Eisai, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe, MSD, Nippon Kayaku, Pfizer, Santen, Taisho-Toyama, Takeda, Teijin Pharma, Consultant for: Teijin Pharma, Chugai, Astellas, Bristol-Meyers, AbbVie, Daiichi-Sankyo, Nihon-Kayaku, Mitsubishi-Tanabe, Pfizer, Takeda, UCB